> > A recent ISO9001 continuous assessment highlighted that our management
> > review was lacking in the suitability (are the systems you have the
> > "right" systems) portion. The problem is the objective evidence. We were
> > told that usually the problem part of the management review is the
> > effectiveness (are your systems operating as they are documented)
> > portion and not the suitability portion.
> >
> > I am looking for how others are fulfilling the suitability portion of
> > the management review and how you provide the objective evidence.
> >
> > Thanks,
> > Ryan Fleser
> > FLESERR -- VTC.COM
Subject: Re: Q:Management Review/O'Leary
Date: Mon, 21 Apr 1997 20:02:35 -0600
From: ISO Standards Discussion <
[email protected]>
From: picker.com "Daniel J. O'Leary"
In management reviews we address the problem with a statement in the minutes. We believe that suitability is a conclusion that you draw based on the information presented. We may say the system is suitable or we may say it is suitable after some changes have been made.
Our minutes, the quality record, have these defined requirements.
The meeting AGENDA
List of attendees
1. Strengths of the Quality System noted during meeting
2. Weakness of the Quality System noted during the meeting
3. Corrective action assignments made during made during the meeting
4. A statement of the suitability and effectiveness of the documented procedures and instructions
5. A statement of the need to redefine management's Quality Policy, Quality Objectives, and commitment to Quality
6. Objective evidence of effectiveness presented during the meeting
The minutes of the meeting are reviewed and approved by the Quality System Management Representative and the Vice President & General Manager.
Dan O'Leary CQA, CQE, CQM, CRE
picker.com